A Post-Marketing Safety Study of Dorzagliatin in Patients With Type 2 Diabetes (BLOOM)

July 9, 2026 updated by: Hua Medicine Limited

A Multicenter Post-Marketing Observational Study to Evaluate the Long-Term Safety of Dorzagliatin in Patients With Type 2 Diabetes Mellitus

The primary objective of this study is to evaluate the long-term safety of Dorzagliatin in a larger population of type 2 diabetes mellitus patients by collecting the post-marketing clinical safety data of Dorzagliatin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study adopts a multicenter, prospective, and observational cohort study design and does not involve randomization, control, and blinding. Patients with type 2 diabetes mellitus who were prescribed Dorzagliatin according to the package insert and physician's judgment in routine medical practice setting will be included, and the data of these patients during 52-week Dorzagliatin treatment will be collected to evaluate the safety of long-term medication.

Study Type

Interventional

Enrollment (Actual)

2024

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029
        • China-Japan Friendship Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

-

Patients must meet all of the following inclusion criteria to be eligible for this study:

  1. Male or female ≥ 18 years of age at the time of signing the informed consent form;
  2. Patients with type 2 diabetes mellitus diagnosed at screening;
  3. Patients who have been prescribed Dorzagliatin according to the package insert and physician's judgment (the prescription should be made before enrolling the patient in this study and is independent of the enrollment decision);
  4. Willingness to participate in the study and sign written informed consent.

Exclusion Criteria:

-

Patients will not be eligible if they meet any of the following criteria:

  1. Other types of clinically diagnosed diabetes, such as type 1 diabetes or other special types of diabetes;
  2. Patients who, in the opinion of the investigator, are at risk of allergy or intolerance to any component of Dorzagliatin;
  3. Patients who, in the judgment of the investigator, cannot complete or are not suitable for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dorzagliatin group
Dorzagliatin tablet (75 mg, BID) treatment for 52 weeks
Drug: Dorzagliatin tablets
During the study, patients should follow the dosing instructions from the investigator, which are made according to the package insert and the patients' conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidences of ADRs and SAEs
Time Frame: 52 weeks
The incidences of adverse drug reactions (ADRs) and serious adverse events (SAEs) as well as ADRs of special interest during the 52-week observation period of Dorzagliatin treatment.
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 52 weeks
The proportion of patients with HbA1c < 7% after 52 weeks of treatment
52 weeks
Blood glucose indicators
Time Frame: 52 weeks
Changes from baseline in glycated hemoglobin (HbA1c) after 52 weeks of treatment with Dorzagliatin
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hua Medicine Limited

Collaborators

Kun Tuo Xincheng Pharmaceutical Researchand Development(Beijing)Co.,Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2024

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

April 30, 2026

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 9, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMM0601

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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